Simplifying Medical Device Regulations: The Power of Partnership Between SimpliMedica and RegMetrics

by Francesca Davis on 20 Sep 2024

Reading time: 3 minutes

SimpliMedica and RegMetrics are working together to create a seamless regulation journey for those who are developing a medical device. Adnan Ashfaq is the founder of SimpliMedica and I spoke to him to find out more about his work and how working with RegMetrics can help his clients.

Established 12 years ago, SimpliMedica has been helping people with their regulation journey for a long time. Adnan said that the reason why he got into this field is because he’s always had a passion for medical devices and by using his background in manufacturing engineering, he founded SimpliMedica to help simplify regulatory compliance.

Navigating the complexities of medical device regulation means that people often have a lot of questions, which Adnan can help answer. Innovators, particularly who are new medtech companies, will often seek the advice and guidance of a consultancy service like SimpliMedica as getting advice and support can help to make the journey simpler. By getting that assistance as early as possible, innovators can begin their regulatory journey and feel supported the whole way, bringing their device to market more seamlessly.

The importance of understanding intended use

When talking about medical devices, Adnan emphasised that it is really, really important to have the intended purpose clear and that the intended use statement being firmed up at an early stage is vital.

To help understand the concept of intended purpose and intended use, Adnan gave us an explanation, detailing the difference between the two. He said that the intended use statement is much broader than just the intended purpose because it includes the intended purpose as well as the intended operating environment, the intended users, the different areas, what specimens are needed, what input Is needed, if there's training, if it's going to be used in an environment which is in a clinical environment or whether it's a home environment, whether it's going to be used by a lay person or whether it's going to be used by a clinician. All these factors make a huge impact and difference on the intended use statement.

The intended use determines the rest of the regulatory journey. It’s very important to be specific about your intended use, because by changing one word, it can change things drastically and this will affect how it is used and potentially how you will need to classify the device. This can then affect the other steps that follow. When developing a medical device, a lot of the process requires you to know what your intended use is, and this is why Adnan highlights how important this is to innovators.

SimpliMedica and RegMetrics

RegMetrics is a great tool to use to gain a lot of regulatory knowledge before talking to consultants like Adnan from SimpliMedica. Adnan explained that if a client has not classified the device, he will point them in the direction of RegMetrics and ask them to use that software. One of the main benefits of using RegMetrics is that it gives you examples and having relevant examples means that those who are unsure or confused about aspects of regulatory compliance are given more appropriate guidance that will help them with developing their medical device.

After clients have used RegMetrics and got their classification, general safety and performance requirements and knowledge of which standards they can use, this is when they engage the regulatory analysis and the roadmap. By using RegMetrics, clients are more prepared for the next stages of the regulatory procedure and that extra assistance from the tool can really help.

Adnan has been using RegMetrics for two years. He finds RegMetrics useful because it's got all of the questions pre -populated and it's thorough. He said “I can be sure that I've covered everything by going through RegMetrics.”

Adnan fully supports RegMetrics and emphasises the importance of working together. The medical device industry should help and support each other because it’s such a small industry. Those within the industry see each other and bump into each other and feel like one big family.

Adnan’s Upcoming Projects

To help explain different parts of the medical industry and medical devices, Adnan is working on a series of podcasts. The podcast will start off with validation, like process validation, equipment validation, etc. Validation is a term that means to validate something and have the assurance that you have quality assurance built in during device development. Whilst this will be his primary focus he said that he would also go into other topics like MDR, IVDR, FDA, regulatory submissions.

The aim of the podcasts is to help those that are new to the whole idea of medical device development. The podcasts should encourage innovators to feel more confident in the process, and therefore their medical device regulation journey should be easier as they have lots of support and knowledge.

Making regulation simpler

Adnan says that as a regulatory consultant he will get involved from the beginning right to the end and supports innovators through the whole journey. Adnan really wants to see people feeling more positive about the regulatory journey, and by using his services, he thinks this may be possible. “The simpler you make this journey for people, the more fun it becomes. And really that's what I like to see in medical device regulations.”

Following up on the importance of supporting each other within the medical device industry, Adnan admits, “developing a medical device is not easy. It's a long journey and it's one that I say to never, never to do alone.” Having consultants like SimpliMedica and tools like RegMetrics means that anyone who is unsure of how to approach regulatory procedure should feel like they have a range of tools that will help them bring their device to market. It’s also great to work alongside consultants like SimpliMedica, knowing that RegMetrics is offering further assistance and making the regulatory procedure easier to work with.